Europe is preparing a “preparatory action” to review existing measures for tackling antimicrobial resistance, identify the gaps, and to determine what products will be needed in future.
The planned Health Emergency Response Authority (HERA) offers the EU the chance to act as a “pipeline coordinator” in bringing promising new classes of antibiotics to the market and to help avoid critical product shortages in future health crises, according to a policy paper by Norwegian and French researchers.
But other interventions will also be needed to simulate innovation and secure access to new antibiotics, including “pull” mechanisms and...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
